TriVascular European Union (EU) Abdominal Stent Graft Trial

This study has been completed.

Sponsor:

TriVascular, Inc.

ClinicalTrials.gov Identifier:

NCT01097772

First Posted: April 2, 2010

Last Update Posted: November 6, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The primary safety endpoint is defined as the proportion of subjects who experience a Serious Adverse Event within 30 days of the initial procedure. [ Time Frame: 30-Days ]

The safety of the TriVascular AAA Stent Graft will be determined by comparing the rate of Serious Adverse Events in the Treatment Group against the rate of Serious Adverse Events in the Control Group within 30 days of the initial procedure.

Secondary Outcome Measures:

To evaluate the performance of the TriVascular AAA Stent-Graft System within 30 days of the initial procedure. [ Time Frame: 30-Days ]

The performance of the TriVascular AAA Stent-Graft System will be determined by comparing the composite success rate in the Treatment Group against an estimated success rate of 80% in the Control Group within 30 days of the initial procedure. The composite success rate is defined as:

Technical Success, defined as successful delivery and deployment of one aortic body and two iliac limbs.

A prospective, consecutively enrolling, non-randomized multi center clinical evaluation of the safety and performance of the TriVascular AAA Stent Graft when used in the treatment of patients with Abdominal Aortic Aneurysms (AAA).

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patient is > 18 years of age

Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)

Patient has signed an Ethics Committee (EC) approved Informed Consent Form

Patient is considered by the treating physician to be a candidate for elective open surgical repair of the AAA (i.e., category I, II, or III per American Society of Anesthesiology (ASA) classification; refer to Appendix III: ASA Classification System). ASA category IV patients may be enrolled provided their life expectancy is greater than 1 year.

Patient has an infrarenal abdominal aortic aneurysm that meets at least one of the following:

Abdominal aortic aneurysm ≥5.0 cm in diameter

Aneurysm has increased in size by 0.5 cm in last 6 months.

Maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment

Patient has patent iliac or femoral arteries that allow endovascular access with the TriVascular AAA device.

Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.

Patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE), PEG-based polymers or nitinol.

Patient has a body habitus that would inhibit X-ray visualization of the aorta

Patient has a limited life expectancy of less than 1 year

Patient is currently participating in another investigational device or drug clinical trial

Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097772